Trial Outcomes & Findings for Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101) (NCT NCT02584634)

NCT ID: NCT02584634

Last Updated: 2023-07-07

Results Overview

Any of the following adverse events (AEs) occurring during the primary DLT observation period that are attributable to one, the other, or both study drugs were classified as DLTs: Grade 4 (life-threatening) neutropenia if \>7 days in duration; febrile neutropenia; Grade \>=3 (severe or life threatening) neutropenic infection; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia \>7 days; Grade 4 anemia; any Grade \>=3 toxicity, except for any of the following: transient (\<=6 hours) Grade 3 (severe) flu like symptoms or fever; transient (\<=24 hours) Grade 3 fatigue, local reactions, or headache that resolved to Grade \<=1 (no AE or mild AE); Grade 3 nausea and/or vomiting, diarrhea or skin toxicity that resolved to Grade \<=1 within 7 days; any Grade \>=3 amylase or lipase abnormality; tumor flare phenomenon; single laboratory values out of normal range that were not related to treatment, did not have any clinical correlate, and resolve to Grade \<=1 within 7 days.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: First 2 cycles (1 cycle = 14 days)
• Results posted on: 2023-07-07

Participant Flow

Participant milestones

Measure	Group A: Avelumab + Crizotinib Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.
Overall Study STARTED	12	31
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	12	31

Reasons for withdrawal

Measure	Group A: Avelumab + Crizotinib Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.
Overall Study Adverse Event	3	5
Overall Study Death	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	1	2
Overall Study Progressive disease	7	15
Overall Study Withdrawal by Subject	1	1
Overall Study Other	0	6

Baseline Characteristics

Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

Baseline characteristics by cohort

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	Total n=43 Participants Total of all reporting groups
Age, Continuous	58.67 Years STANDARD_DEVIATION 10.43 • n=93 Participants	53.32 Years STANDARD_DEVIATION 11.59 • n=4 Participants	54.81 Years STANDARD_DEVIATION 11.41 • n=27 Participants
Age, Customized <65 years	9 Participants n=93 Participants	25 Participants n=4 Participants	7 Participants n=27 Participants
Age, Customized 65-<75 years	2 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants
Age, Customized 75-<85 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	19 Participants n=4 Participants	25 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	12 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	8 Participants n=93 Participants	17 Participants n=4 Participants	25 Participants n=27 Participants
Race/Ethnicity, Customized White	4 Participants n=93 Participants	13 Participants n=4 Participants	17 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	11 Participants n=93 Participants	30 Participants n=4 Participants	41 Participants n=27 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age Range	59.5 Years n=93 Participants	54 Years n=4 Participants	55 Years n=27 Participants

PRIMARY outcome

Timeframe: First 2 cycles (1 cycle = 14 days)

Population: The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug), and either experienced DLT during the first 2 cycles (1 cycle = 14 days), or completed the observation period for the first 2 cycles of treatment.

Any of the following adverse events (AEs) occurring during the primary DLT observation period that are attributable to one, the other, or both study drugs were classified as DLTs: Grade 4 (life-threatening) neutropenia if >7 days in duration; febrile neutropenia; Grade >=3 (severe or life threatening) neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia >7 days; Grade 4 anemia; any Grade >=3 toxicity, except for any of the following: transient (<=6 hours) Grade 3 (severe) flu like symptoms or fever; transient (<=24 hours) Grade 3 fatigue, local reactions, or headache that resolved to Grade <=1 (no AE or mild AE); Grade 3 nausea and/or vomiting, diarrhea or skin toxicity that resolved to Grade <=1 within 7 days; any Grade >=3 amylase or lipase abnormality; tumor flare phenomenon; single laboratory values out of normal range that were not related to treatment, did not have any clinical correlate, and resolve to Grade <=1 within 7 days.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=28 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Number of Participants With Dose-limiting Toxicities (DLTs): Phase 1b	5 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.

OR is defined as complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 from start date (the date of first dose of study treatment) until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Per RECIST v1.1: CR is defined as the disappearance of all target or non-target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm and all lymph nodes must be non-pathological in size (<10 mm short axis). PR is defined as a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Percentage of Participants With Objective Response (OR): Phase 2	25.0 Percentage of participants Interval 5.5 to 57.2	51.6 Percentage of participants Interval 33.1 to 69.8	—

PRIMARY outcome

Timeframe: Baseline up to 60 months

Population: The analysis population included all participants who received at least one dose of study drug in Group B. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. Results for Group A are not reported for this outcome measure according to the protocol.

Per RECIST v1.1: CR is defined as the disappearance of all target or non-target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm and all lymph nodes must be non-pathological in size (<10 mm short axis).

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=31 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Percentage of Participants With CR for Group B: Phase 2	3.2 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.

TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs	12 Participants	30 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with Grade >= 3 TEAEs	7 Participants	23 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with treatment-related TEAEs	12 Participants	28 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with Grade >= 3 treatment-related TEAEs	6 Participants	16 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with SAEs	5 Participants	21 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with treatment-related SAEs	2 Participants	6 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs leading to discontinuation of avelumab	3 Participants	10 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs leading to discontinuation of crizotinib	6 Participants	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs leading to discontinuation of lorlatinib	—	2 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs leading to discontinuation of any study drug	6 Participants	10 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs leading to discontinuation of all study drugs	3 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with treatment-related TEAEs leading to discontinuation of avelumab	2 Participants	9 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with treatment-related TEAEs leading to discontinuation of crizotinib	5 Participants	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with treatment-related TEAEs leading to discontinuation of lorlatinib	—	2 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs leading to death	1 Participants	4 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with treatment-related TEAEs leading to death	0 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with infusion-related reactions	5 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Screening up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant was classified according to the first treatment received.

The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Shift tables were provided to examine the distribution of laboratory toxicities. The following parameters had met the criteria of CTCAE grade shift change from Grade <=2 at baseline to Grade 3 or 4 post baseline: anemia, lymphocyte count decreased, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, Creatine phosphokinase (CPK) increased, Gamma glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hypermagnesemia, hypertriglyceridemia, hypoalbuminemia, hyponatremia, lipase increased, serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Blood bilirubin increased	0 Participants	1 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypermagnesemia	0 Participants	1 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Anemia	0 Participants	3 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Lymphocyte count decreased	1 Participants	2 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Lymphocyte count increased	0 Participants	2 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Neutrophil count decreased	1 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 White blood cell decreased	1 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Alanine aminotransferase increased	3 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Aspartate aminotransferase increased	2 Participants	1 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Cholesterol high	0 Participants	5 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 CPK increased	0 Participants	2 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 GGT increased	1 Participants	5 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypercalcemia	0 Participants	2 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hyperglycemia	1 Participants	1 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypertriglyceridemia	0 Participants	7 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypoalbuminemia	0 Participants	1 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hyponatremia	1 Participants	3 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Lipase increased	1 Participants	5 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Serum amylase increased	0 Participants	1 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hemoglobin increased	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Platelet count decreased	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Alkaline phosphatase increased	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Creatinine increased	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hyperkalemia	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypernatremia	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypocalcemia	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypoglycemia	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypokalemia	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypomagnesemia	0 Participants	0 Participants	—
Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 Hypophosphatemia	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Screening up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant was classified according to the first treatment received.

Pre-defined criteria in vital signs: pulse rate <50 beats per minute, pulse rate >120 bpm, sitting diastolic blood pressure (DBP) increase and decrease in change from baseline of >= 20 millimeter of mercury (mmHg), sitting systolic blood pressure(SBP) < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Number of Participants With Vital Signs Meeting Pre-defined Criteria Pulse rate <50 bpm	2 Participants	0 Participants	—
Number of Participants With Vital Signs Meeting Pre-defined Criteria Pulse rate >120 bpm	0 Participants	4 Participants	—
Number of Participants With Vital Signs Meeting Pre-defined Criteria Sitting DBP change >= 20 mmHg increase	2 Participants	13 Participants	—
Number of Participants With Vital Signs Meeting Pre-defined Criteria Sitting DBP change >= 20 mmHg decrease	5 Participants	8 Participants	—
Number of Participants With Vital Signs Meeting Pre-defined Criteria Sitting SBP <90 mmHg	1 Participants	4 Participants	—
Number of Participants With Vital Signs Meeting Pre-defined Criteria Sitting SBP change >= 30 mmHg increase	1 Participants	11 Participants	—
Number of Participants With Vital Signs Meeting Pre-defined Criteria Sitting SBP change >= 30 mmHg decrease	3 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.

DC is defined as objective response (CR or PR) or stable disease (SD) per RECIST v.1.1 from the date of first dose of study treatment until disease progression or death due to any cause. The DCR is the proportion of patients with DC. Per RECIST v1.1: CR is defined as the disappearance of all target or non-target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm. PR is defined as a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Disease Control Rate (DCR)	58.3 Percentage of participants Interval 27.7 to 84.8	71.0 Percentage of participants Interval 52.0 to 85.8	—

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug and who had confirmed complete response or partial response. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.

DR: time from first documented occurrence of response (PR or CR) until date of first documented PD or death due to underlying cancer. Per RECIST 1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions; any pathological lymph nodes assigned as target lesions/non-target lesions have a reduction in short axis to <10 mm. PR: at least a >=30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. PD: at least a >=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of new lesions. Participants with no PD and were still alive by 02 Feb 2020, were censored at last adequate tumor assessment. Kaplan-Meier method was used for DR analysis.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=3 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=16 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Duration of Response (DR)	3.7 Month Interval 3.7 to 4.6	14.7 Month Interval 3.7 to The upper bound of the 95% confidence interval was not estimable due to limited number of events.	—

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug and who had confirmed complete response or partial response. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.

TTR is defined, for participants with an objective response (CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which is subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=3 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=16 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Time to Tumor Response (TTR)	1.4 Months Interval 1.4 to 6.9	1.8 Months Interval 1.3 to 3.7	—

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.

PFS is defined as the time from start date (the date of first dose of treatment) to the date of the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST v1.1: PD: a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Progression-free Survival (PFS)	3.7 Months Interval 1.5 to 5.5	6.4 Months Interval 3.7 to 9.2	—

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years)

Population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.

OS is defined as the time from start date (the date of first dose of treatment) to the date of death due to any cause.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Kaplan-Meier Estimates of Overall Survival (OS)	16.4 Months Interval 5.4 to 27.6	32.9 Months Interval 10.7 to The upper bound of the 95% confidence interval was not estimable due to limited number of events.	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the pharmacokinetic (PK) parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

Cmax of crizotinib in the presence of avelumab was observed directly from data.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Maximum Plasma Concentration (Cmax) of Crizotinib in The Presence of Avelumab	281 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 74	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

Tmax of crizotinib in the presence of avelumab was observed directly from data as time of first occurrence.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Time to Cmax (Tmax) of Crizotinib in The Presence of Avelumab	2.03 Hours Interval 0.0 to 8.08	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

AUCtau of crizotinib in the presence of avelumab was calculated by Linear/Log trapezoidal method. Dose interval is defined as after single dose from time zero to the next dose (after single dose and at steady state).

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Area Under The Plasma Concentration-Time Curve During The Dosing Interval Time Course (AUCtau) of Crizotinib in The Presence of Avelumab	2755 nanograms*hours per millilitre (ng*h/mL) Geometric Coefficient of Variation 82	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Apparent Plasma Clearance (CL/F) of Crizotinib in The Presence of Avelumab	90.76 Liter per hour (L/h) Geometric Coefficient of Variation 82	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

Cmax of crizotinib metabolite PF-06260182 in the presence of avelumab was observed directly from data.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Cmax of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab	84.11 ng/mL Geometric Coefficient of Variation 91	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

Tmax of crizotinib metabolite PF-06260182 in the presence of avelumab was observed directly from data as time of first occurrence.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Tmax of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab	3.02 Hours Interval 0.0 to 8.08	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

AUCtau of crizotinib metabolite PF-06260182 in the presence of avelumab was calculated by Linear/Log trapezoidal method. Dose interval: single dose from time zero to the next dose (after single dose and at steady state).

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
AUCtau of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab	789.1 ng*h/mL Geometric Coefficient of Variation 116	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

MRAUCtau of metabolite PF-06260182 in the presence of avelumab was calculated (MRAUCtau=Metabolite AUCtau/parent AUCtau). Parent=crizotinib, metabolite=PF-06260182

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Metabolite to Parent Ratio for AUCtau (MRAUCtau) of PF-06260182 in The Presence of Avelumab	0.2779 Ratio Geometric Coefficient of Variation 33	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure.

MRCmax of metabolite PF-06260182 in the presence of avelumab was calculated (MRCmax=Metabolite Cmax/parent Cmax). Parent=crizotinib, metabolite=PF-06260182

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Metabolite to Parent Ratio for Cmax (MRCmax) of PF-06260182 in The Presence of Avelumab	0.2902 Ratio Geometric Coefficient of Variation 25	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for lorlatinib in Group B. Group A is not evaluable for this outcome measure.

Cmax of lorlatinib in the presence of avelumab was observed directly from data.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=26 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Cmax of Lorlatinib in The Presence of Avelumab	596.9 ng/mL Geometric Coefficient of Variation 33	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for lorlatinib in Group B. Group A is not evaluable for this outcome measure.

Tmax of lorlatinib in the presence of avelumab was observed directly from data.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=26 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Tmax of Lorlatinib in The Presence of Avelumab	1.23 Hours Interval 0.933 to 4.33	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for lorlatinib in Group B. Group A is not evaluable for this outcome measure.

AUCtau of lorlatinib in the presence of avelumab was calculated by Linear/Log trapezoidal method. Dose interval: single dose from time zero to the next dose (after single dose and at steady state).

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=19 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
AUCtau of Lorlatinib in The Presence of Avelumab	5807 ng*h/mL Geometric Coefficient of Variation 42	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for lorlatinib in Group B. Group A is not evaluable for this outcome measure.

AUClast of lorlatinib in the presence of avelumab.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=26 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Area Under The Plasma Concentration Time Curve From Time of Dosing to The Last Collection Time Point (AUClast) of Lorlatinib in The Presence of Avelumab	4872 ng*h/mL Geometric Coefficient of Variation 52	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, 8, and 24 hours (prior to Day 2 lorlatinib dose) post dose on Day 1 of Cycle 2

Population: The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for lorlatinib in Group B. Group A is not evaluable for this outcome measure.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=19 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
CL/F of Lorlatinib in The Presence of Avelumab	16.97 L/h Geometric Coefficient of Variation 44	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, and 168 hours post dose of avelumab on Cycle 1 Day 1.

Population: The analysis population included participants who received at least one dose of study drug and who had at least one post-dose concentration measurement above the lower limit of quantification for avelumab.

Cmax of avelumab in the presence of crizotinib was observed directly from the data in Group A. Cmax of avelumab in the presence of lorlatinib was observed directly from the data in Group B.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=8 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=16 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Cmax of Avelumab in The Presence of Crizotinib (Group A) or Lorlatinib (Group B) After Single Dose of Avelumab	193.2 micrograms/milliliter (ug/mL) Geometric Coefficient of Variation 14	195.7 micrograms/milliliter (ug/mL) Geometric Coefficient of Variation 28	—

SECONDARY outcome

Timeframe: Pre-dose, 1, and 168 hours post dose of avelumab on Cycle 2 Day 1

Population: The analysis population included participants who received at least one dose of study drug and who had at least one post-dose concentration measurement above the lower limit of quantification for avelumab.

Cmax of avelumab in the presence of crizotinib was observed directly from the data in Group A. Cmax of avelumab in the presence of lorlatinib was observed directly from the data in Group B.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=8 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=17 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Cmax of Avelumab in The Presence of Crizotinib (Group A) or Lorlatinib (Group B) After Multiple Doses of Avelumab	174.5 ug/mL Geometric Coefficient of Variation 35	169.4 ug/mL Geometric Coefficient of Variation 68	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 2-5, 11, 17, 23, 29, 35, and 47.

Population: The analysis population included participants who received at least one dose of study drug and who had least one observation. Number of Participants Analyzed represents the total number of participants in the analysis population for this outcome measure. Number Analyzed represents the number of participants with concentration measurement above lower limit of quantification at each visit. Group B was not evaluable for this outcome measure.

Ctrough is defined as predose concentration following multiple doses. Ctrough of avelumab in the presence of crizotinib was observed directly from the data in Group A.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 2 Day 1	11.76 ug/mL Geometric Coefficient of Variation 68	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 3 Day 1	16.26 ug/mL Geometric Coefficient of Variation 53	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 4 Day 1	16.71 ug/mL Geometric Coefficient of Variation 34	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 5 Day 1	14.21 ug/mL Geometric Coefficient of Variation 46	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 11 Day 1	26.64 ug/mL Geometric Coefficient of Variation 4	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 17 Day 1	30.59 ug/mL Geometric Coefficient of Variation 9	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 23 Day 1	30.63 ug/mL Geometric Coefficient of Variation 15	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 29 Day 1	30.72 ug/mL Geometric Coefficient of Variation 55	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 35 Day 1	37.31 ug/mL Geometric Coefficient of Variation 27	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Crizotinib (Group A) Following Multiple Doses of Avelumab Cycle 47 Day 1	40.91 ug/mL Geometric Coefficient of Variation 15	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 2-5, 11, 17, 23, 29, 35, 41, and 47.

Population: The analysis population included participants who received at least one dose of study drug and who had least one observation. Number of Participants Analyzed represents the total number of participants in the analysis population for this outcome measure. Number Analyzed represents the number of participants with concentration measurement above lower limit of quantification at each visit. Group A was not evaluable for this outcome measure.

Ctrough is defined as predose concentration following multiple doses. Ctrough of avelumab in the presence of lorlatinib was observed directly from the data in Group B.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=25 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 2 Day 1	16.86 ug/mL Geometric Coefficient of Variation 88	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 3 Day 1	16.99 ug/mL Geometric Coefficient of Variation 116	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 4 Day 1	23.71 ug/mL Geometric Coefficient of Variation 80	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 5 Day 1	26.74 ug/mL Geometric Coefficient of Variation 68	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 11 Day 1	31.31 ug/mL Geometric Coefficient of Variation 71	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 17 Day 1	32.69 ug/mL Geometric Coefficient of Variation 60	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 23 Day 1	33.20 ug/mL Geometric Coefficient of Variation 56	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 29 Day 1	25.77 ug/mL Geometric Coefficient of Variation 66	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 35 Day 1	31.27 ug/mL Geometric Coefficient of Variation 47	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 41 Day 1	30.81 ug/mL Geometric Coefficient of Variation 59	—	—
Trough Serum Concentration (Ctrough) of Avelumab in The Presence of Lorlatinib (Group B) Following Multiple Doses of Avelumab Cycle 47 Day 1	39.63 ug/mL Geometric Coefficient of Variation 64	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1-5, then every 12 weeks thereafter, end of treatment/withdrawal, and 30 days after last avelumab dose (up to a maximum of 5 years)

Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab.

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. Baseline is defined as the last assessment on or prior to the date/time of the first dose of avelumab.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=12 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants n=43 Participants Including all the participants from Group A and Group B.
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status ADA never-positive	9 Participants	25 Participants	34 Participants
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status ADA ever-positive	3 Participants	6 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline

Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 from the corresponding assay sample with at least one baseline biomarker measurement.

PD-L1 protein expression is determined by using Combined Positive Score (CPS), which is the percentage of viable tumor and tumor-infiltrated immune cells (restricted to lymphocytes and macrophages) within or directly associated with tumor cell strands showing partial or complete membrane staining using the SP263 antibody. Positive is defined as CPS>=1% and negative is defined as CPS <1%.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=9 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=24 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression Positive	7 Participants	20 Participants	—
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression Negative	2 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of tumor infiltrating CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.

Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as >=1% and negative is defined as <1%.

Outcome measures

Measure	Group A: Avelumab + Crizotinib n=10 Participants Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=22 Participants Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.	All Participants Including all the participants from Group A and Group B.
Number of Participants With Positive Tumor Infiltrating CD8+ Lymphocytes Positive	6 Participants	4 Participants	—
Number of Participants With Positive Tumor Infiltrating CD8+ Lymphocytes Negative	4 Participants	18 Participants	—

Adverse Events

Group A: Avelumab + Crizotinib

Serious events: 5 serious events

Other events: 12 other events

Deaths: 10 deaths

Group B: Avelumab + Lorlatinib

Serious events: 21 serious events

Other events: 28 other events

Deaths: 15 deaths

Serious adverse events

Measure	Group A: Avelumab + Crizotinib n=12 participants at risk Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 participants at risk Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Cardiac tamponade	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Pericardial effusion	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Chest pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Disease progression	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pyrexia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Hepatobiliary disorders Immune-mediated hepatitis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Cellulitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Clostridium difficile infection	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Pneumonia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Postoperative wound infection	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Sepsis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Tonsillitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Central nervous system vasculitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Cerebral haemorrhage	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Cerebral infarction	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Seizure	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Confusional state	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Delirium	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Nephrolithiasis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Deep vein thrombosis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Superior vena cava occlusion	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Sudden death	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Measure	Group A: Avelumab + Crizotinib n=12 participants at risk Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule.	Group B: Avelumab + Lorlatinib n=31 participants at risk Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule.
Blood and lymphatic system disorders Anaemia	25.0% 3/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	19.4% 6/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Atrioventricular block first degree	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Pericardial effusion	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Ear and labyrinth disorders Tinnitus	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Endocrine disorders Hypothyroidism	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.8% 8/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Eye disorders Dry eye	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Eye disorders Keratitis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Asthenia	16.7% 2/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Chest pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Chills	25.0% 3/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Fatigue	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Hypothermia	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Localised oedema	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Mucosal inflammation	16.7% 2/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Oedema	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Oedema peripheral	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	38.7% 12/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Peripheral swelling	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pyrexia	25.0% 3/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Swelling face	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Constipation	16.7% 2/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.6% 7/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Diarrhoea	25.0% 3/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.6% 7/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Dry mouth	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Nausea	58.3% 7/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Oesophageal pain	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Stomatitis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Vomiting	50.0% 6/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	19.4% 6/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Hepatobiliary disorders Immune-mediated hepatitis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Cellulitis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Conjunctivitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Cystitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Gastroenteritis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Lower respiratory tract infection	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Rhinitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Tooth abscess	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 2/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	19.4% 6/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Procedural pain	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Alanine aminotransferase increased	33.3% 4/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	29.0% 9/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Amylase increased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Aspartate aminotransferase increased	25.0% 3/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.6% 7/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood alkaline phosphatase increased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood cholesterol increased	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	61.3% 19/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood creatine phosphokinase increased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood creatinine increased	16.7% 2/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood lactate dehydrogenase increased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Electrocardiogram QT prolonged	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Gamma-glutamyltransferase increased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Hypophonesis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Lipase increased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Neutrophil count decreased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Weight decreased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Weight increased	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.8% 8/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations White blood cell count decreased	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Acidosis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Decreased appetite	41.7% 5/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	19.4% 6/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	58.1% 18/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypocalcaemia	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypoglycaemia	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	41.9% 13/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 3/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	19.4% 6/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dizziness	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dysgeusia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Headache	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Hemiparesis	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Lethargy	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Memory impairment	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Migraine	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Neuropathy peripheral	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.6% 7/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Paraesthesia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Somnolence	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.2% 1/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Confusional state	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Hallucination	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Hallucination, visual	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Insomnia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	19.4% 6/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Haematuria	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Nephropathy toxic	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Proteinuria	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.7% 3/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Reproductive system and breast disorders Vaginal discharge	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.6% 7/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 2/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Lung opacity	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.9% 4/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	33.3% 4/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.1% 5/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Proctalgia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood triglycerides increased	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Hyperaesthesia	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Restlessness	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/12 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.5% 2/31 • Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER